At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 711 enrolled
Drug / intervention
RV3-BB +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized, Double Blind, Parallel Group Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine Administered at a High, Mid and Low Titre as a 3 Dose Neonate Schedule or Administered at a High Titre as a 3 Dose Infant Schedule.
In Brief
A Phase 2 clinical trial evaluating RV3-BB and Placebo for Rotavirus Infections. Completed, enrolled 711 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotavirus Infections
CountriesMalawi
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 2018
Enrollment StartJun 2018
Primary CompletionJan 2020
TodayJul 2026
First PostedMar 30, 2018
Enrollment StartJun 15, 2018
Primary CompletionJan 27, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.3 years ago
Interventions
RV3-BBbiological
Oral administration
Placebobiological
Oral administration